A Study of Treatment With RO6864018 in Virologically Suppressed Participants With Chronic Hepatitis B Virus (HBV) Infection

Roche

Status and phase: Completed; Phase 2

Conditions: Hepatitis B, Chronic

Treatments: Drug: RO6864018; Drug: Tenofovir; Drug: Entecavir; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02391805

NP28938

Details and patient eligibility

About

This randomized, multicenter, partially double-blind, placebo-controlled study is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and antiviral effects of treatment with RO6864018 in virologically suppressed participants with chronic HBV infection.

Enrollment: 31 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronic hepatitis B infection
• Positive test for HBsAg for more than 6 months prior to randomization
• HBsAg titer greater than or equal to (>/=) 250 international units per milliliter (IU/mL) at Screening
• Treatment with any nucleoside/nucleotide analogue for >/= 1 year with ongoing entecavir and/or tenofovir treatment at randomization and for at least 3 months prior to randomization
• HBV DNA less than (<) 90 IU/mL for at least the preceding 6 months
• HBeAg positive at randomization and for at least 6 months prior to randomization

Exclusion criteria

• Pregnant or lactating women
• Documented history of HBV genotype D
• History or other evidence of bleeding from esophageal varices
• History of decompensated liver disease, chronic liver disease other than HBV infection, or any evidence of metabolic liver disease
• Positive test for hepatitis A, hepatitis C, or human immunodeficiency virus (HIV)
• Documented history of hepatitis D infection
• History of or suspicion of hepatocellular carcinoma
• History of immunologically mediated disease
• History of organ transplantation
• History of thyroid disease
• Significant acute infection

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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31 participants in 6 patient groups, including a placebo group

Placebo, Every Other Day (QOD)

Placebo Comparator group

Description:

Placebo orally (PO) QOD for 12 weeks + noninvestigational entecavir or tenofovir as prescribed by participant's physician

Treatment:

Drug: Tenofovir

Drug: Placebo

Drug: Entecavir

Placebo, Once a Week (QWk)

Placebo Comparator group

Description:

Placebo PO QWk for 12 weeks + noninvestigational entecavir or tenofovir as prescribed by participant's physician

Treatment:

Drug: Tenofovir

Drug: Placebo

Drug: Entecavir

RO6864018, 1200 milligrams (mg) QOD

Experimental group

Description:

RO6864018 1200 mg PO QOD for 12 weeks + noninvestigational entecavir or tenofovir as prescribed by participant's physician

Treatment:

Drug: Tenofovir

Drug: RO6864018

Drug: Entecavir

RO6864018, 1200 mg QWk

Experimental group

Description:

RO6864018 1200 mg PO QWk for 12 weeks + noninvestigational entecavir or tenofovir as prescribed by participant's physician

Treatment:

Drug: Tenofovir

Drug: RO6864018

Drug: Entecavir

RO6864018, 800 mg QOD

Experimental group

Description:

RO6864018 800 mg PO QOD for 12 weeks + noninvestigational entecavir or tenofovir as prescribed by participant's physician

Treatment:

Drug: Tenofovir

Drug: RO6864018

Drug: Entecavir

RO6864018, 800 mg QWk

Experimental group

Description:

RO6864018 800 mg PO QWk for 12 weeks + noninvestigational entecavir or tenofovir as prescribed by participant's physician

Treatment:

Drug: Tenofovir

Drug: RO6864018

Drug: Entecavir